Sanford Health, announced that a spinal implant developed by Sanford Clinic Neurosurgeon, Wilson Asfora, MD, Sanford Clinic Neurosurgery & Spine, has received United States Food and Drug Administration (FDA) 510(k) market clearance as a lumbar intervertebral body fusion device. On August 14, 2009, the FDA gave 510(k) clearance to the Asfora Bullet Cage, a product which is designed for use in posterior lumbar interbody fusion surgeries to treat degenerative disc disease. The Asfora Bullet Cage will be manufactured and sold by Medical Designs, LLC.
“We congratulate Dr. Asfora on the FDA approval of his spinal implant,” said Dave Link, Sanford Health Executive Vice President. “At Sanford Health, our goal is to foster an environment which supports the efforts of our physicians to develop innovative solutions for the global health care market.”
Commenting on the FDA approval, Dr. Asfora said: “the 510 (k) clearance of the Asfora Bullet Cage represents the culmination of a decade of clinical research. Clinical experience to date demonstrates up to a 98 percent rate of interbody fusion of one or two levels in hundreds of cases using simply locally harvested bone without unexpected complications and without the use of pedicle screws and Bone Morphogenic Protein.”